safety of autologous bone marrow derived mesenchymal stem cells in erectile dysfunction

Conditions: Erectile Dysfunction

Summary: this phase i clinical trial is designed to evaluate the safety of autologous mesenchymal stem cells (msc) injected intracavernously.

cellgram-ed is autologous bone marrow-derived mesenchymal stem cells ex vivo expanded for approximately 30 days. ten patients (diabetes -associated ed; 5 patients, postprostatectomy; 5patients) will be injected cellgram-ed directly into the intracavernous. patient will be evaluated the safety and potential efficacy of msc.

Eligibility criteria:
inclusion criteria: postprostatectomy erectile dysfunction * a man aged 20 or older * who is willing to consent to participate in the study concerned with improving sexual activity after prostatectomy, the man has maintained normal sexual activity prior to prostatectomy * prior to prostatectomy psa (prostate specific antigen) level\<10 ng/ml * at the time of prostatectomy, pathological gleason sum ≤7 * at the time of prostatectomy, pathological stage ≤ t2c * 2 years or more postprostatectomy patients with psa level ≤ 0.04 ng/ml without additional therapy after prostatectomy * who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral pde5i(phos-phodiesterasetype-5 inhibitors) within last 8weeks. * iief, ef(erectile function) domain score is under 17 * have a consistent partner who is willing to engage in sexual activity more than twice per month during the study. diabetes-associated erectile dysfunction * hba1c is between 6.5% and 10% of man over 20 years of age with diabetes * who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral pde5i within last 8weeks. * iief, ef domain score is under 17 * who is willing to consent to participate in the study concerned with improving sexual activity * have a consistent partner who is willing to engage in sexual activity more than twice per month during the study. exclusion criteria: * history of bone marrow disorders * serum ast/alt \> 3 x upper limit of normal or creatinine \> 1.5 x upper limit of normal * history of hypersensitivity against a gentamycin * severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure * positive for human immunodeficiency virus (hiv), hepatitis b virus (hbv), hepatitis c virus (hcv) and syphilis test * positive for psa or cea or afp (carcinoembryonic antigen), history of cancer in the last five years (except prostatic cancer) uncontrolled hypertension or hypotension (systolic blood pressure \> 170 or \ 100 or \< 50 mm hg) * hba1c exhibit greater than 10% * men on anticoagulant treatment * have a severe infectious disease * testosterone level is less than 200ng/dl * have a penile implant or willing to it * patients with morphological changes of the penis * patient's partner is trying to conceive during the trial period * unwilling to participate in the study * participating in other clinical trials in the past 30 days * unable to compliance with protocol * inappropriate patients to participate in the study according to the investigator